Identity
- Trade Name
- Curaplex FDA UDI
- Generic Name
- Isolation gown, reusable FDA UDI
- Device Name
- Curaplex Personal Protection Kit with Disposable Masks and Gloves FDA UDI
- Model / Reference
- 670198-KIT FDA UDI
- Description
- Curaplex Personal Protection Kit with Disposable Masks and Gloves FDA UDI
Identifiers
- Catalog Number
- 670198-KIT FDA UDI
- Primary DI / UDI-DI
- 00812277036664 FDA UDI
- FDA Product Code
- LYU FDA UDI
- GMDN Term
- Isolation gown, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Isolation gown, single-useIsolation gown, reusableInfectious waste spill kit
Curaplex by Bound Tree Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bound Tree Medical, Llc
Sources (1)
- FDA UDI 4c9e40d0-d3e9-4194-9be5-30a99583a25c 34 fields · synced May 30, 2026